The following data is part of a premarket notification filed by Harald Nordin S.a with the FDA for Harald Nordin Glassix Glass Fiber Composite Dental Post.
| Device ID | K003221 |
| 510k Number | K003221 |
| Device Name: | HARALD NORDIN GLASSIX GLASS FIBER COMPOSITE DENTAL POST |
| Classification | Post, Root Canal |
| Applicant | HARALD NORDIN S.A 100 MAIN STREET; SUITE 120 Concord, MA 01742 |
| Contact | James Delaney |
| Correspondent | James Delaney HARALD NORDIN S.A 100 MAIN STREET; SUITE 120 Concord, MA 01742 |
| Product Code | ELR |
| CFR Regulation Number | 872.3810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-16 |
| Decision Date | 2000-10-25 |